For regulatory, compliance, and quality consultancies the world over, demonstrating comprehensive capabilities comes down to showcasing work done for global innovators.
At IDEC, we’ve proudly supported more than 100 client projects, and we’ve worked with organizations across North America, Europe, the Middle East, and the Asia-Pacific region.
To learn more about our competencies applied to pharmaceutical industry needs, read two select success stories below.
Customer Success: Supporting a Pharmaceutical Company with the Development of a Global Product in Japan
A large US client with a global footprint was actively developing a drug product for sale on the global level. They intended to enter the Japanese market simultaneously with others around the world.
The client engaged IDEC’s R&D team in order to assess and account for Japanese regulatory requirements through their development process. Since then, IDEC has worked closely with various local constituents (KOLs, PMDA, CROs, and others) to implement the program for Japan.
IDEC began the design of the Japanese development program in 2010, and the client has utilized IDEC as a strategic partner across a broad spectrum of activities in various locations.
Our successful engagement moved in four stages:
Stage One
IDEC prepared an initial assessment report for the product development program that summarized opportunities and risk and prioritized a comprehensive list of indications to consider. The client utilized this report to initiate their product development program.
Stage Two
IDEC supported the client by managing and responding to PMDA consultations as they confirmed the development plan and prepared a complete data package for all relevant indications in Japan.
Stage Three
IDEC worked closely with the client to select and manage CROs to implement clinical trials in Japan. IDEC also led the selection and management of Key Opinion Leaders (KOLs) and the formation of an Advisory Board for the target disease area.
Stage Four
IDEC leveraged its in-house and external resources to prepare a comprehensive and compelling eCTD for Japanese submission. IDEC and the client collaborated closely to manage all inquiries from the PMDA across CMC, Non-Clinical, and Clinical areas.
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Customer Success: Supporting a Japanese Client with the Development of a Product Licensed from Abroad
Stage One
IDEC prepared the initial assessment report for the client’s program—the program was not yet in-licensed by the client. The report demonstrated possible development scenarios in Japan for the client, and that led their decision-makers to move to in-license the program.
Stage Two
IDEC led the implementation of a PMDA consultation to confirm the development plan for the program in Japan. Due to the available data package from overseas, only minimal additional clinical and non-clinical data were required for the program to proceed in Japan.
Stage Three
IDEC collaborated with the client to select and manage CROs and testing sites. IDEC then implemented the additional studies for the Japanese regulatory requirements and led the selection and management of well-suited Key Opinion Leaders (KOLs) in the specified disease area.
Stage Four
IDEC leveraged both in-house and external resources to prepare a comprehensive eCTD for Japanese submission. Working closely with the client, IDEC managed all inquiries (CMC, Non-Clinical, and Clinical) from the PMDA through to complete product approval in January 2016.